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  • Procjena zdravstvenih tehnologija u Hrvatskoj: sadašnjost i budućnost

    dr. sc. Mirjana Huić, dr. med. Služba za razvoj, istraživanje i zdravstvene tehnologije

    Agencija za kvalitetu i akreditaciju u zdravstvu i socijalnoj skrbi Zagreb, Hrvatska

    2. nacionalna konferencija, Zagreb, 3.12.2015.

  • Croatian process of decision-making and HTA process

    Agency for Quality and Accreditation

    in Healthcare and Social Welfare - HTA Department

    “ASSESSMENT” (Currently not mandatory)

    HTA document

    with recomm- endation

    Recommendation

    CHIF Board

    “DECISION”

    HTA document with recommendation

    HTA document

    with recomm- endation

    Croatian Health Insurance Fund (CHIF)

    “Drugs Committee” and “Medical Devices Committee”

    “APPRAISAL”

    MoH

    “DECISION”

    Hospitals Management “DECISION”

    Industry submission files

    EUnetHTA and HTA Network (Article 15,

    CBHC Directive)

    Full Core HTA and Core HTA for Rapid

    REA of Pharmaceuticals and other health

    technologies

    National/regional work produced in

    another country/region

    National adaptation

    Request

    Request

    Request Active

    collaborative production

  • Služba za razvoj, istraživanje i zdravstvene tehnologije (Služba za HTA), listopad 2009.

    Plan i program za uspostavu HTA:

    • Croatian HTA Guideline, http://aaz.hr/hr/procjena-zdravstvenih-tehnologija

    • International collaboration, http://aaz.hr/hr/projekti, http://www.aaz.hr

    • National collaboration, education and HTA promotion (congress, meetings, WSs, publications in Croatian language), http://aaz.hr/hr/procjena-zdravstvenih-tehnologija/edukativni-materijali

    • Production of HTA Reports (national, international), http://aaz.hr/hr/procjena-zdravstvenih- tehnologija/baza

    • Scientific Publications, http://aaz.hr/hr/procjena-zdravstvenih-tehnologija/publikacije

    • Web page, http://www.aaz.hr/, http://aaz.hr/hr/procjena-zdravstvenih-tehnologija; http://aaz.hr/hr/projekti

  • Challenges (limited legal framework, human resources, funding, appropriate stakeholders involvement in HTA process)

    Factors facilitating HTA establishment in Croatia

  • Zakonski okvir u Hrvatskoj

    • 2006, Strategy of the development of the Croatian Health Care System 2006- 2011

    • September 2012, Croatian National Health Care Strategy 2012-2020

    • 2007, Act on Quality of Health Care

    • November 2011, Act on Quality of Health Care and Social Welfare (Ordinance on HTA process and reporting)

    • November 2012, draft proposal Ordinance on HTA process and reporting to Croatian MoH (in process)

    • July 2013, Ordinance regarding reimbursement on drugs, HTA not mandatory (if requested - 1 month timeframe)

  • “The Croatian Guideline for Health Technology Assessment Process and Reporting”, 1st edition, February 2011 (with international peer-review process), http://aaz.hr/hr/procjena-zdravstvenih-tehnologija

    Contents

    I Introduction and legal framework

    II HTA process

    1 Topics suggestion and selection process

    2 Scope prepared

    3 Assessment process

    4 Advice (Appraisal) process

    5 HTA Report

    6 Guide for the Economic evaluation of health technologies: Croatia Appendix I: Bibliography of recommended HTA Guidelines and methodology references

    Appendix II: A Code of Practice for Declaring and Dealing with Conflicts of Interest in HTA process

    Appendix III: Authorship

    Appendix IV: Selected Data Sources on Croatian Population Health, Healthcare Resource Use and Costs

  • International collaboration, http://aaz.hr/hr/projekti, http://www.aaz.hr “If you want to go fast, go alone. If you want to go far, go with other.”

    • EU Projects (EUnetHTA JAs; European study on Quantifying Utility of Investment in Protection from Tobacco – EQUIPT; Sustainable intEgrated care modeLs for multi-morbidity: delivery, FInancing and performance - SELFIE)

    • HTAi, ISPOR, ISPOR HTA Roundtable Europe, ISPOR HTA Council

    • HTA Network

    • WHO National Contact Point on HTA

    • ISPOR HTA Training Programe (June 2015)

  • EUnetHTA Joint Actions | www.eunethta.eu

    European network for HTA (JA1, 2010-2012;

    JA2, 2012–2015; JA3, 2016-2019)

  • Health Technology Life-cycle

    9

    Early scientific advice

    Rapid REA Additional

    Evidence Generation

    HTA / REA

    U se

    o f

    te ch

    n o

    lo gy

    in h

    ea lt

    h c

    ar e

    Time line of innovation Submission

    Template

  • EUnetHTA documents, tools, process

    Methodological Guidelines

    Tools

    • Core Model (as flexible format and content)

    • Planned and Ongoing Projects Database (POP)

    • Submission template for drugs and medical devices

    Process

    • Scoping meetings with Stakeholders

  • The Domains of the HTA Core Model® - assessing dimensions of value

    HTA Core Model DOMAINS

    1. Health problem and current use of technology

    2. Description and technical characteristics

    3. Safety

    4. Clinical effectiveness

    5. Costs and economic evaluation

    6. Ethical analysis

    7. Organisational aspects

    8. Social aspects

    9. Legal aspects

    SCOPE R

    ap id

    R EA

    C o

    m p

    re h

    en si

    ve /F

    u ll

    H TA

    R e

    lia b

    le , t

    im e

    ly , t

    ra n

    sp ar

    e n

    t,

    in fo

    rm at

    io n

    V al

    u e

    ?

    11

  • June 12, 2013 12

  • EUnetHTA evidence submission template

    13

    • Procedures and processes

    • Methodological guidance

    • Decision making criteria

    Company

    submission of

    evidence

    Local Assessment

    Local appraisal Local decision making

    EUnetHTA evidence submission

    template (all evidence requirements)

    European Assessment

    Company

    submission of

    evidence

    Template adaptation process Template adaptation process

    Evidence

    requirements

    for European

    assessment

    Evidence

    requirements

    for local

    (national or

    regional)

    assessment

  • • Production of HTA Reports (national, international), http://aaz.hr/hr/procjena-zdravstvenih-tehnologija/baza

    • Web page, http://www.aaz.hr/, http://aaz.hr/hr/procjena-zdravstvenih-tehnologija; http://aaz.hr/hr/projekti

  • Sadržaj

    Sažetak

    I Okvir za postupak procjene zdravstvenih tehnologija u Hrvatskoj

    II Procjena zdravstvene tehnologije

    1. Uvod i metode

    2. Bolest u kojoj se primjenjuje zdravstvena tehnologija

    3. Opis zdravstvene tehnologije

    4. Klinička učinkovitost i sigurnost (neželjeni događaji) i kvaliteta života

    4.1. Sustavni pregledi kliničke učinkovitosti i sigurnosti (engl. Systematic Review, SR)

    4.2. Randomizirana kontrolirana ispitivanja (engl. Randomized Controlled Trials, RCTs)

    4.3. Opservacijska istraživanja (engl. Observational studies)

    5. Troškovi i ekonomske analize

    5.1. Troškovi i ekonomske analize u zdravstvu

    5.2. Sažetak publikacija CUA ili CEA analiza

    5.3. Hrvatska

    6. Organizacijski, legalni i etički aspekti

    6.1. Organizacijski aspekti

    6.2. Smjernice i stajališta profesionalnih stručnih društava

    6.3. Legalni i etički aspekti

    7. Preporuke ustanova za procjenu zdravstvenih tehnologija i HTA (engl. Health Technology Assessment) publikacije

    8. Zaključak i preporuke

    9. Literatura

  • Agency HTA Database, http://aaz.hr/hr/procjena-zdravstvenih-tehnologija/baza

    HTA reports (31 finished), 2011- November 2015 (>65% on Medical devices/procedures)

    Rapid HTA at national level

    HTA at national level

    HTA at international level

    4 16 11

  • Transcatheter Aortic Valve Implantation-TAVI: HTA; Tandem mass spectrometry in expanded newborn screening for inherited metabolic disorders: HTA; Particle Beam Radiation Therapies for Cancer: HTA; Intensity-Modulated Radiation Therapy, IMRT: HTA; Endovascular abdominal aortic aneurysm (AAA) repair: HTA; Biofeedback and Neurofeedback treatments for psychiatric disorders: HTA; Impact of triclosan-coated sutures on surgical site infection: HTA; Insulin glargine and insulin detemir in combination with oral antidiabetic therapy in patient with type 2 DM: HTA;

    Sitagliptin and sitagliptin with metformin therapy in patients with type 2 diabetes mellitus: HTA;

    Drugs in the treatment of lung cancer (afatinib, erlotinib, gefitinib, crizotinib, pemetrexed): HTA;

    Sofosbuvir in Chronic Hepatitis C: HTA;

    Drugs in the treatment of prostate cancer (cabazitaxel, enzalutamide, abiraterone)

  • EUnetHTA JA 2010-2012

    • Facilitation of national strategies for continuous development and sustainability of HTA

    • HTA training and capacity building

    • Anti-